FDA.report

Snowden-Pencer

Primary DI
10885403143625
Brand
Snowden-Pencer
Company
STERIS CORPORATION
Model
32-0122
Catalog number
32-0122
Device description
DIAMOND-JAW NEEDLE HOLDER BLUNT WIRE TWISTER 15CM (6"), 2500 JAW
Published
2018-07-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HYAFORCEPS, WIRE HOLDING

Product Code Classifications

CodeDeviceSpecialtyClass
HYAForceps, Wire HoldingGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10885403143625PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088540314362510885403143625

GMDN Terms

TermDefinition
Wire twisterA surgical instrument specifically designed to twist surgical wire after this has been applied to the site in order to tighten the loop or binding that has been made by the surgeon. The loose ends of the wire are inserted into and gripped by the jaws of this device, and the surgeon pulls a handle which spins the spirally grooved centre piece, thereby twisting and tightening the wire. It is typically used in orthopaedic procedures. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)323-9088Customer_Support@BD.com
+1(800)548-4873xx@xx.xx

Regulatory Flags

DUNS number
021599373
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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