FDA.reportPublic FDA data

N/A

Primary DI
00614138102583
Brand
N/A
Company
TETRA MEDICAL SUPPLY CORP.
Model
0195S7
Catalog number
0195S7
Device description
STERILE IMPERVIOUS STOCKINET 9 X 48
Published
2022-08-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITGBandage, Cast

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITGBandage, CastPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00614138102583PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00614138102583006141381025836141381025830614138102583

GMDN Terms#

Term, Definition table
TermDefinition
StockinetteA knitted, seamless, expandable tubing, typically made of cotton, that is open at both ends and intended to be used to hold bandages in place; to place uniform pressure on a leg, finger, arm, or other part of an extremity; to pad the area under a cast or splint; or to cover a stump when a prosthesis is worn. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
18006214041sales@tetramed.com

Regulatory Flags#

DUNS number
047580212
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
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00614138016040N/A1212021212022022-08-19
00614138016057N/A1212031212032022-08-19
00614138016064N/A1212041212042022-08-19
00614138016071N/A1212051212052022-08-19
00614138016088N/A1212061212062022-08-19
00614138025332N/A12007P12007P2022-08-19
00614138025349N/A12007N12007N2022-08-19
00614138105119N/A1214101214102022-08-19
00614138105126N/A1214111214112022-08-19
00614138105133NA1214121214122022-08-19
00614138105140N/A1214131214132022-08-19
00614138105157N/A1214141214142022-08-19
00614138105164N/A1214151214152022-08-19
00614138106147N/A1213021213022022-08-19
00614138106161N/A1213041213042022-08-19
00614138113428N/A2149-012149-012022-08-19
00614138113435N/A2149-022149-022022-08-19
00614138113442N/A2149-032149-032022-08-19
00614138113459N/A2149-042149-042022-08-19
00614138113466N/A2149-062149-062022-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
40080196284192MEDLINEMEDLINE INDUSTRIES, INC.ITG2026-01-22
40080196832331MEDLINEMEDLINE INDUSTRIES, INC.ITG2026-01-22
50192253045862WebrilCardinal Health 200, LLCITG2025-09-23
50192253045879WebrilCardinal Health 200, LLCITG2025-09-23
50192253045886WebrilCardinal Health 200, LLCITG2025-09-23
50192253045923WebrilCardinal Health 200, LLCITG2025-09-23
16975675788557RESCUE ESSENTIALSEMSRUN GROUPITG2025-07-18
07290100665619Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDITG2025-07-08
07290100665626Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDITG2025-07-08
07290100665633Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDITG2025-07-08
07290100665640Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDITG2025-07-08
00840117344389CurPro Undercast Padding, 100% Polyester, 2" x 4 yd Dynarex CorporationITG2025-06-05
00810180842099CurPro Undercast Padding , 100% Polyester, 3" x 4 yd Dynarex CorporationITG2025-06-05
00810180842105CurPro Undercast Padding, 100% Polyester, 4" x 4 yd Dynarex CorporationITG2025-06-05
00810180842112CurPro Undercast Padding, 100% Polyester, 6" x 4 yd Dynarex CorporationITG2025-06-05
00810180842129CurPro Undercast Padding, 100% Polyester, 8" x 4 ydDynarex CorporationITG2025-06-05
20192253045755CurityCardinal Health 200, LLCITG2025-03-19
50192253045763CurityCardinal Health 200, LLCITG2025-03-19
20192253045779CurityCardinal Health 200, LLCITG2025-03-19
20192253045793CurityCardinal Health 200, LLCITG2025-03-19
00840117342019CurPro Tubular Elastic Dressing Retention Net, 1/2" x 25 yd.Dynarex CorporationITG2025-02-17
00840117342026CurPro Tubular Elastic Dressing Retention Net, 1 1/2" x 25 yd.Dynarex CorporationITG2025-02-17
00840117342033CurPro Tubular Elastic Dressing Retention Net, 2.3" x 25 yd.Dynarex CorporationITG2025-02-17
00840117342040CurPro Tubular Elastic Dressing Retention Net, 3.2" x 25 yd. Dynarex CorporationITG2025-02-17
50885632106512MediChoiceOWENS & MINOR DISTRIBUTION, INC.ITG2025-01-09
50885632106536MediChoiceOWENS & MINOR DISTRIBUTION, INC.ITG2025-01-09
50197106823017CARDINAL HEALTHCardinal Health 200, LLCITG2024-12-04
06430053260238WOODCASTDassiet OyITG2024-08-11
06430053260252WOODCASTDassiet OyITG2024-08-11
06430053265837WOODCASTDassiet OyITG2024-08-11