FDA.reportPublic FDA data

SUPRAMID

Primary DI
00816848021110
Brand
SUPRAMID
Company
S JACKSON INC
Model
Code MPR-50
Catalog number
Code MPR-50W
Device description
"3/8 Circle Reverse Cutting Needle (18.7mm), USP 5-0 SUPRAMID white monofilament Nylon, 18"""
Published
2017-08-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GARSuture, Nonabsorbable, Synthetic, Polyamide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GARSuture, Nonabsorbable, Synthetic, PolyamideGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816848021117PackageGS112In Commercial Distribution
00816848021110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081684802111710816848021117
00816848021110008168480211108168480211100816848021110

GMDN Terms#

Term, Definition table
TermDefinition
Nylon suture, non-bioabsorbable, monofilamentA single-strand (monofilament), synthetic, non-bioabsorbable thread made of nylon (a polyamide polymer) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
8003685225sales@supramid.com

Regulatory Flags#

DUNS number
069277028
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816848020007SUPRAMID EXTRACode 2CR-30Code 2CR-30-W2017-08-07
00816848020014SUPRAMID EXTRACode 2CR-40Code 2CR-40-W2017-08-07
00816848020021SUPRAMID EXTRACode 2EA-40Code 2EA-40-W2017-08-07
00816848020038SUPRAMID EXTRACode 2ER-20Code 2ER-20-W2017-08-07
00816848020045SUPRAMID EXTRACode 2ER-30Code 2ER-30-W2017-08-07
00816848020052SUPRAMID EXTRACode 2ER-40Code 2ER-40-W2017-08-07
00816848020069SUPRAMID EXTRACode 2FO-40Code 2FO-40-W2017-08-07
00816848020076SUPRAMID EXTRACode 2GS-1-30Code 2GS-1-30-W2017-08-07
00816848020083SUPRAMID EXTRACode 2GS-2-30Code 2GS-2-30-W2017-08-07
00816848020090SUPRAMID EXTRACode 2JB-20BCode 2JB-20B2017-08-08
00816848020106SUPRAMID EXTRACode 2JB-20Code 2JB-20-W2017-08-08
00816848020113SUPRAMID EXTRACode 2LA-40Code 2LA-40-W2017-07-24
00816848020120SUPRAMID EXTRACode 2LC-30Code 2LC-30-W2017-08-08
00816848020137SUPRAMID EXTRACode 2LC-40Code 2LC-40-W2017-08-08
00816848020144SUPRAMID EXTRACode 2LC-40BCode 2LC-40B2017-07-24
00816848020199SUPRAMID EXTRACode 2OS-40Code 2OS-40W2017-08-08
00816848020205SUPRAMID EXTRACode 2S-1-30Code 2S-1-30W2017-08-08
00816848020212SUPRAMID EXTRACode 2S-1-40Code 2S-1-40W2017-08-08
00816848020236SUPRAMID EXTRACode 2S-2-40Code 2S-2-40W2017-08-08
00816848020243SUPRAMID EXTRACode 2VN-40Code 2VN-40W2017-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07757093013747SUTUMEDUnilene S.A.C.GAR2024-09-19
07757093013891SUTUMEDUnilene S.A.C.GAR2024-09-19
07757093013068SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013280SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013563SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013587SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013600SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013877SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013952SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014041SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014096SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014188SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014362SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014393SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014560SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014713SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014744SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014768SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014881SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014898SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014911SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015048SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015093SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015147SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015253SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015277SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015284SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015437SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015482SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015741SUTUMEDUnilene S.A.C.GAR2023-01-06