FDA.reportPublic FDA data

Sterile Labels

Primary DI
20849771052924
Brand
Sterile Labels
Company
KEY SURGICAL, INC.
Model
SL214
Catalog number
SL214
Device description
Sterile Labels - Custom TNHO0004
Published
2023-04-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYVLABEL OR TAG, STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYVLabel Or Tag, SterileGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20849771052924PackageGS1100In Commercial Distribution
10849771052927PrimaryGS10
00849771052920Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2084977105292420849771052924
1084977105292710849771052927
00849771052920008497710529208497710529200849771052920

GMDN Terms#

Term, Definition table
TermDefinition
Procedural medication labelling setA collection of devices intended to provide clinical staff with a standardized method to label medications, medication containers (e.g., syringes, medicine cups, basins), or other solutions in and outside of the sterile field in perioperative and other procedural settings. It typically includes a permanent marking pen and various labels typically made of moisture resistant plastic material and provided with standard medication/drug/solution text (e.g., lidocaine, heparin, morphine sulfate, saline, sterile water) which can be further qualified using the pen; the labels may also include additional text fields (e.g., for date, initials). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)541-7995regulatory@keysurgical.com

Regulatory Flags#

DUNS number
604056226
Device count
2
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
true
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
10849771050374NASilicone Clamp CoversVS2012023-03-31
10849771050381NASilicone Clamp CoverVS2022023-01-26
10849771050398NASilicone Clamp CoverVS2032023-01-26
00849771031284Key Surgical Silicone Clamp CoversVS-103VS1032020-12-09
00849771048367NASurgical Plastic InstrumentKS3472023-01-26
00849771048374NASurgical Plastic InstrumentsKS3482023-04-04
10849771013379Key Surgical Cautery Tip CleanerTC200NSTC200NS2025-04-04
00849771048596NAPlastic Sterilization TrayPST2100SB2023-01-26
00849771048602NAPlastic Sterilization TrayPST3100SB2023-01-26
00849771048619NAPlastic Sterilization TrayPST3200SB2023-01-26
00849771052692NAPlastic Sterilization TrayPST0100SB2023-01-26
00849771052715NAPlastic Sterilization TrayPST3200SBC12023-01-26
00849771052708NAPlastic Sterilization TrayPST1100SB2023-01-26
00849771048626NAPlastic Sterilization TraysPST3300SB2023-05-08
10849771047428NAInstrument OrganizerCSDH1002022-11-22
10849771047435NAInstrument OrganizerCSDH1022022-11-22
10849771047442NAInstrument OrganizerCSDH1052022-11-22
10849771047459NAInstrument OrganizerCSDH3002022-11-22
10849771047466NAInstrument OrganizerCSDH2002022-11-22
10849771047473NAInstrument OrganizerCSDH5052022-11-22

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Primary DI, Brand, Company table
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