FDA.report

Henry Schein

Primary DI
20304040000124
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
900-7472
Catalog number
900-7472
Device description
HS PC31 5-0 BK MN NYL 18"/45CM
Published
2015-09-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
20304040000124PackageGS112In Commercial Distribution
00304040000120PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2030404000012420304040000124
00304040000120003040400001203040400001200304040000120

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 needle intended to be disposed of after single use. 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 intended to be used in a sterile condition.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00N/A

Sterilization Methods

Method

Regulatory Flags

DUNS number
012430880
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
false

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00304040187463Zirlux920004692000462026-02-04
00304040187470Zirlux920004792000472026-02-04
00304040187487Zirlux920004892000482026-02-04
00304040187517Zirlux920005192000512026-02-04
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00304040187531Zirlux920005392000532026-02-04
00304040187548Zirlux920005492000542026-02-04
00304040187555Zirlux920005592000552026-02-04
00304040187562Zirlux920005692000562026-02-04
00304040187579Zirlux920005792000572026-02-04
00304040187586Zirlux920005892000582026-02-04
00304040187593Zirlux920005992000592026-02-04
00304040187616Zirlux920006192000612026-02-04
00304040187623Zirlux920006292000622026-02-04
00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

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14946585362337CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
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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