FDA.reportPublic FDA data

NA

Primary DI
20849771050357
Brand
NA
Company
KEY SURGICAL, INC.
Model
Sterile Labels
Catalog number
SL106
Device description
Sterile Labels - Custom, 10 labels per panel, 1 panel per pouch, 100 pouches per Box
Published
2023-04-24
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
20849771050357PackageGS1100In Commercial Distribution
00849771032137PreviousGS10
10849771050350PrimaryGS10
00849771050353Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2084977105035720849771050357
00849771032137008497710321378497710321370849771032137
1084977105035010849771050350
00849771050353008497710503538497710503530849771050353

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
10
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
00849771052708NAPlastic Sterilization TrayPST1100SB2023-01-26
00849771052159NAES50ES502023-01-26
00849771048237NAK-Wire and Steinmann Pin DispenserKI710172025-08-11
00849771049036NAK-Wires and Steinmann PinsKI711312025-08-11
00849771049289NAK-Wires and Steinmann PinsKI711852025-08-11
00849771049500NAK-Wires and Steinmann PinsKI712532025-08-11
00849771048169NAK-Wire and Steinmann Pin DispensersKI710022025-04-30
00849771049012NAK-Wires and Steinmann PinsKI711242025-04-30
00849771049128NAK-Wires and Steinmann PinsKI711612025-04-30
60849771050416Electro LubeEL101EL1012025-04-24
00849771046356K-Wire and Steinmann Pin DispensersKI71042KI710422025-04-16
00849771046363K-Wire and Steinmann Pin DispensersKI71044KI710442025-04-16
00849771046370K-Wire and Steinmann Pin DispensersKI71046KI710462025-04-16
00849771046387K-Wire and Steinmann Pin DispensersKI71047KI710472025-04-16
00849771046394K-Wire and Steinmann Pin DispensersKI71048KI710482025-04-16
00849771013372Key Surgical Cautery Tip CleanerTC200NSTC200NS2025-04-04
50849771050617NAK-Wire and Pin CoversC1092025-01-29
10724995225022Electro LubeEL201EL2012024-10-03
00849771048190NAK-Wire and Steinmann Pin DispensersKI710062024-10-03
00849771052562Key Surgical Pipe CleanersPC100CPC100C2024-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B050SL1000021Sterile LabelsTYPENEX MEDICAL LLCLYV2026-03-17
17540277009646PharmaTagsRMAC Surgical, IncLYV2026-03-12
17540277009639PharmaTagsRMAC Surgical, IncLYV2026-03-03
17540277000001PharmaTagsRMAC Surgical, IncLYV2026-02-06
10754027700104PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700111PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700142PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700173PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700265PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700715PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700722PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700739PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700746PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700753PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700777PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700784PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700791PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700807PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700814PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700821PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700838PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700845PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700852PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700869PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700876PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700883PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700890PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700906PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700913PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700920PharmaTagsRMAC Surgical, IncLYV2026-02-02