FDA.reportPublic FDA data

SYNTHETIC CAST PADDING 6" 6/BG

Primary DI
00610570167388
Brand
SYNTHETIC CAST PADDING 6" 6/BG
Company
Bird & Cronin, LLC
Model
08149966
Published
2022-08-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

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
00610570167388PrimaryGS10
00610570029136Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00610570167388006105701673886105701673880610570167388
00610570029136006105700291366105700291360610570029136

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose medical fibre paddingA roll, sheet or preformed shape of synthetic (e.g., polyester, polypropylene) or natural (e.g., cotton) fibre intended to be applied to and/or compress a local area of the body for various preventative/therapeutic applications (e.g., in compression bandaging, padding under casts and splints, padding for anatomical depressions), typically over intact and healthy skin. It is intended for use in the home or a clinical setting. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
045975349
Device count
6
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00610570191390B-Cool Chest & AB Binder Wrap081425212023-05-23
00610570191406B-Cool Chest & AB Binder Wrap081425222023-05-23
00610570191413B-Cool Chest & AB Binder Wrap081425242023-05-23
50610570191418B-Cool Chest & AB Binder Wrap081425232023-05-23
00610570191451B-Cool Super Sling Plus Universal (Complete Set)081482612023-02-20
00610570191581Short Anklizer Low Profile Walker XS081491372023-02-20
00610570191598Short Anklizer Low Profile Walker Small081491382023-02-20
00610570191604Short Anklizer Low Profile Walker Medium081491392023-02-20
00610570191611Short Anklizer Low Profile Walker Large081491402023-02-20
00610570191628Short Anklizer Low Profile Walker X-LG081491412023-02-20
00610570191444B-Cool Super Sling Universal (Sling Only)081482602023-02-16
00610570063277APNEA HEAD & CHIN STRAP081482232022-10-31
00610570088065CONTOURED CERV COLLAR 2" UNIV081400392022-10-31
00610570115655PRODY BULB HOLDER081482202022-10-31
00610570166756UNIVERSAL ARM SLING081400152022-08-01
00610570174607ENVELOPE STYLE ARM SLING XS081400612022-08-02
00610570174614ENVELOPE STYLE ARM SLING SM081400622022-08-02
00610570174621ENVELOPE STYLE ARM SLING MD081400632022-08-02
00610570174638ENVELOPE STYLE ARM SLING LG081400642022-08-02
00610570174645ENVELOPE STYLE ARM SLING XL081400652022-08-02

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