FDA.report

Henry Schein

Primary DI
00304040070987
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5702957
Catalog number
5702957
Device description
DISPOSABLE SKIN STAPLER 35R REGULAR STERILE
Published
2022-10-31
Public version status
New
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
GAGStapler, surgical

Product Code Classifications

CodeDeviceSpecialtyClass
GAGStapler, SurgicalGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00304040070987PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040070987003040400709873040400709870304040070987

GMDN Terms

TermDefinition
Skin stapler/staple, non-bioabsorbableA hand-held manual, surgical instrument preloaded with non-bioabsorbable skin staples designed to apply the staples to approximate the free skin edges of an incision or wound. The staples (which may be clip-like) are made of metal [e.g., stainless steel or titanium (Ti)] and intended to be removed once the wound has sufficiently healed. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
012430880
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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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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20612479282852McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479282883McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
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20612479282906McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
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20612479282920McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479282937McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479282944McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479283019McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
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20612479283224McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
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20612479283248McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
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20612479284597McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
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20705036043543ETHICONETHICON ENDO-SURGERY, LLCGAG2025-08-22
20888277368290MEDLINE RENEWALMEDLINE INDUSTRIES, INC.GAG2025-02-14
20888277378879MEDLINEMEDLINE INDUSTRIES, INC.GAG2025-02-14
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