FDA.report

NYLON

Primary DI
20790986006274
Brand
NYLON
Company
C.P. MEDICAL CORPORATION
Model
1667B
Catalog number
1667B
Published
2016-02-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
GARSuture, Nonabsorbable, Synthetic, Polyamide

Product Code Classifications

CodeDeviceSpecialtyClass
GARSuture, Nonabsorbable, Synthetic, PolyamideGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20790986006274PackageGS112In Commercial Distribution
10790986006277PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2079098600627420790986006274
1079098600627710790986006277

GMDN Terms

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.

Sterilization Methods

Method
Ethylene Oxide

Regulatory Flags

DUNS number
807404611
Device count
1
DM exempt
false
Premarket exempt
false
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
true

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00790986000001CP Cotton Umbilical TapeCP10A2024-03-29
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00790986000568CP Cotton Umbilical TapeCP12A2015-09-24
20790986000555CP Cotton Umbilical TapeCP11A2015-09-24
20790986006298FN NEEDLESFN18-51TFN18-51T2016-02-19
20790986006304FN NEEDLESFN18-3TFN18-3T2016-02-19
20790986006311FN NEEDLESFN18-1TFN18-1T2016-02-19
20790986006328FN NEEDLESFN17-51TFN17-51T2016-02-19
20790986006335FN NEEDLESFN17-3TFN17-3T2016-02-19
20790986006342FN NEEDLESFN17-1TFN17-1T2016-02-19
20790986006878FN NEEDLESFN18-53T2017-11-06
10790986001005MONO-DOXM1842016-07-26
20790986001019MONO-DOXM3042016-07-26
20790986001026MONO-DOXM305M3052016-06-13
20790986001033MONO-DOXM310M3102016-06-13
20790986001040MONO-DOXM311M3112016-06-13
20790986001057MONO-DOXM3152016-07-26
20790986001071MONO-DOXM317M3172016-07-26
20790986001088MONO-DOXM332M3322016-06-13
20790986001095MONO-DOXM333M3332016-06-13

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
14946585362283CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362290CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362306CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362313CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362320CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362337CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362344CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362351CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362368CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362375CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362382CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362399CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362405CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362412CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
03661522103128CARDIONYL®PETERS SURGICALGAR2026-03-05
03661522103135CARDIONYL®PETERS SURGICALGAR2026-03-05
14946585347785CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-03
14946585348416CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-03
14946585348423CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-03
14946585348430CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-03
14946585348492CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-03
14946585355292CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-03
04946585357374CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-03
14946585357487CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-03
14946585358002CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-02-10
14946585042222CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-01-26
14946585037143CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2025-11-13
04946585037153CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2025-11-13
14946585041935CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2025-11-13
14946585042208CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2025-11-13