FDA.report

Stryker

Primary DI
00810041636355
Brand
Stryker
Company
Provision
Model
3910-500-756
Published
2019-12-12
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
HWQPasser

Product Code Classifications

CodeDeviceSpecialtyClass
HWQPasserOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810041636355PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810041636355008100416363558100416363550810041636355

GMDN Terms

TermDefinition
Suturing unit, reprocessedA non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft; it may in addition knot and/or cut the sutures as they are placed. This is a previously used single-use device that has been processed for an additional single-use patient application.

Sterilization Methods

Method

Regulatory Flags

DUNS number
016889401
Device count
1
DM exempt
true
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
false
Sterilization required before use
false

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