FDA.report

NanoPass

Primary DI
07613252632955
Brand
NanoPass
Company
STRYKER CORPORATION
Model
CAT01356
Catalog number
CAT01356
Device description
NANOPASS REACH 45 RIGHT
Published
2015-09-04
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

Contact Domains

Product Codes

CodeName
HWQPASSER

Product Code Classifications

CodeDeviceSpecialtyClass
HWQPasserOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07613252632955PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07613252632955076132526329557613252632955

GMDN Terms

TermDefinition
Suturing unit, single-useA 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 single-use device.

Device Sizes

TypeValueUnit
Angle45degree

Sterilization Methods

Method

Contacts

PhoneEmail
+1(866)624-4422xx@xx.xx

Regulatory Flags

DUNS number
187502109
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
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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