FDA.reportPublic FDA data

Sterile Labels

Primary DI
B050SL1000021
Brand
Sterile Labels
Company
TYPENEX MEDICAL LLC
Model
SL-100002
Device description
Sterile Label Kit: 1 - 10 UP Custom Printed Label Sheet 1 - Utility Marker
Published
2026-03-17
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

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
B050SL1000021PackageHIBCC25In Commercial Distribution
B050SL1000020PrimaryHIBCC0

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature68 Degrees Fahrenheit75 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600850213
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
10810050855850Microscope SlidesPS0404G2026-05-14
10810050855867Microscope SlidesPS0404L2026-05-14
10810050855874Microscope SlidesPS0404N2026-05-14
10810050855881Microscope SlidesPS0404P2026-05-14
10810050855898Microscope SlidesPS0404Y2026-05-14
10810050855904Embedding CassetteEC0616YXT-LASER2026-05-14
10810050855911Embedding CassetteEC0616PXT-LASER2026-05-14
10810050855928Embedding CassetteEC0616WXT-LASER2026-05-14
10810050855935Embedding CassetteEC0616EXT-LASER2026-05-14
10810050855843Rad ControlRT0301XBA2026-05-06
10810050855836Microscope SlidesLC0105B2026-03-23
20810050855833Microscope SlidesLC0105B2026-03-23
B050SL1000020Sterile LabelsSL-1000022026-03-17
00810050851923Specimen Collection SwabSW0202SW02022020-06-01
00810050851909Specimen Collection SwabSW0102SW01022020-06-01
00810050852388Anterior Nasal SwabSW0302SW03022020-08-20
00810050855815ThermoFlo®60612026-01-26
00810050855808Typenex Introducer SetMS2335S2025-11-17
10810050855805Typenex Introducer SetMS2335S2025-11-17
00810050854436Typenex Heat and Moisture Exchanger with FilterRE01012022-04-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07540277000011PharmaTagsRMAC Surgical, IncLYV2026-06-09
07540277000004PharmaTagsRMAC Surgical, IncLYV2026-02-06
10198459214035Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-12-22
10198459204401Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-12-08
10198459205842Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-12-08
10198459189777Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-11-24
10198459166938Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-11-17
10198459181269Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-11-17
10198459159404Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-10-20
10198459148750Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-10-13
10198459141454Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-10-06
10198459141546Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-10-06
10198459133381Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-29
10198459134517Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-29
10198459122712Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-22
10198459122729Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-22
10198459122736Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-22
10198459115929Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-15
10198459119774Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-15
10198459119781Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-15
10198459119798Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-15
10198459120725Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-15
10198459120732Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-15
10198459109164Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-08
10198459074493Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-08-04
10198459075056Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-08-04
10198459078750Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-08-04
10195327655099Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-07-29
10195327668808Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-07-29
10198459024825Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-07-29