FDA.reportPublic FDA data

MEDLINE

Primary DI
20888277384221
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
3055R
Catalog number
3055R
Device description
3055 @ENDOTRAC SYS, HOOK BLADE, FOR ENDO
Published
2025-02-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GESBLADE, SCALPEL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GESBlade, ScalpelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888277384221PackageGS16In Commercial Distribution
10888277384224PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088827738422120888277384221
1088827738422410888277384224

GMDN Terms#

Term, Definition table
TermDefinition
Hand ligament surgical release instrumentA hand-held manual surgical instrument designed for use during percutaneous/mini-open surgery to cut a ligament of the hand causing pathological compression. It is typically probe-like in form with a cutting element (e.g., blade, toothed wire) and is typically dedicated to a specific procedure (e.g., carpal tunnel release, trigger finger release). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250381863572Scalpel handleSpiggle & Theis Medizintechnik GmbHGES2025-09-24
06938535542884Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535542891Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535542914Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535542945Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535542969Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535542976Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535542983Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543003Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543010Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543027Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543034Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543041Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543058Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543065Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543072Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543089Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543096Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543102Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543119Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543126Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543133Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543232Sterile Disposable Surgical Blade without Plastic Handle (Carbon Steel )Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543249Sterile Disposable Surgical Blade without Plastic Handle (Carbon Steel )Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543263Sterile Disposable Surgical Blade without Plastic Handle (Carbon Steel )Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543294Sterile Disposable Surgical Blade without Plastic Handle (Carbon Steel )Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543317Sterile Disposable Surgical Blade without Plastic Handle (Carbon Steel )Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543324Sterile Disposable Surgical Blade without Plastic Handle (Carbon Steel )Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543331Sterile Disposable Surgical Blade without Plastic Handle (Carbon Steel )Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543355Sterile Disposable Surgical Blade without Plastic Handle (Carbon Steel )Huaiyin Medical Instruments Co., Ltd.GES2025-09-05