FDA.reportPublic FDA data

MEDLINE

Primary DI
10888277681330
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
50495510RH
Catalog number
50495510RH
Device description
5049-5-510 HOFFMANN II COMPACT CONNECTI
Published
2025-03-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JECCOMPONENT, TRACTION, INVASIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JECComponent, Traction, InvasiveOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888277681330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088827768133010888277681330

GMDN Terms#

Term, Definition table
TermDefinition
External orthopaedic fixation system reprocessed componentA component of an external fixation system intended to be used to stabilize a fractured bone/joint. It may be a specially designed frame, clamp, rod, pin, rod-to-rod coupling, rod-to-pin coupling, post, fastener, wire, bolt, washer, nut, hinge, ring, socket, bar, screw, or other device. This is a single-use device that has previously been used on a patient and has been subjected to additional processing and manufacturing for an additional single-use patient application.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
false
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
true

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
10888277681231MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681248MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681255MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681262MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681279MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681286MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681293MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681309MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681316MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681323MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681347MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681354MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277680463MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-31
10888277680616MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-31
10888277681026MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-31
10888277681071MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-31
10888277681392MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-31
M97031000900010Tissue Protector, DynaFuseMedshape, Inc.JEC2024-04-01
M97031001200010Tube Caddy, DynaFuseMedshape, Inc.JEC2024-04-01
00861988000334DigiFix Sterile KitVIRAK ORTHOPEDICS LLCJEC2023-08-15
M97022000400330Protection Sleeve, 3.3mm, DynaNailMedshape, Inc.JEC2023-06-21
M97022000401400Protective Sleeve, 14mm, DynaNailMedshape, Inc.JEC2023-06-21
M97022000406330Parallel 3.3mm Protection Sleeve, DynaNail, DynaNailMedshape, Inc.JEC2023-06-21
M97029001000000Retention knob, Frame Assembly, DynaNail MiniMedshape, Inc.JEC2023-06-14
M97029001300000Tissue Protector, DynaNail MiniMedshape, Inc.JEC2023-06-14
M97029001500020Trial Sizer 110-140mm, DynaNail MiniMedshape, Inc.JEC2023-06-14
M97029001500030Trial Sizer 60-100mm, DynaNail MiniMedshape, Inc.JEC2023-06-14
M97029002200780Inner Sleeve, 7mm, Frame Assy, DynaNail MiniMedshape, Inc.JEC2023-06-14
M97029002300000Compression knob, Frame Assy DynaNail MiniMedshape, Inc.JEC2023-06-14
M9702400030000Tap, Quick Connect, Reusable, Helical Ridge Medshape, Inc.JEC2023-04-06