FDA.report

Paul Banditt

Primary DI
D955SPA221
Brand
Paul Banditt
Company
Terlain Enterprises, Inc.
Model
SPA22
Device description
Paul Banditt 22 Spatula, SE
Published
2023-12-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GAFSpatula, Surgical, General & Plastic Surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GAFSpatula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D955SPA221PrimaryHIBCC0

GMDN Terms

TermDefinition
Orthopaedic cement spatulaA hand-held manual surgical instrument designed to spread orthopaedic bone cement material onto a surface. It is typically made of high-grade stainless steel and consists of a handle proximally and a flat blunt blade (no sharp edges) at the distal tip. Progressing from the handle to the distal tip, the shaft or the blade may be straight, curved, or turn at various angles. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
177465051
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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

Other Devices From This Company

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D9553300KEY1Paul Banditt3300-KEY 2023-12-11
D95543411Paul Banditt434-1 2023-12-11
D955BC169511Paul BandittBC1695-12023-12-11
D955BC169521Paul BandittBC1695-2 2023-12-11
D955BCU0R0L1Paul BandittBCU0R0L 2023-12-11
D955BCU1R1L1Paul BandittBCU1R1L 2023-12-11
D955BCU2R2L1Paul BandittBCU2R2L 2023-12-11
D955BCU71001Paul BandittBCU7100 2023-12-11
D955BCU71101Paul BandittBCU7110 2023-12-11
D955BCU71201Paul BandittBCU7120 2023-12-11
D955BCU72521Paul BandittBCU7252 2023-12-11
D955BCU72541Paul BandittBCU7254 2023-12-11
D955BCU9361Paul BandittBCU936 2023-12-11
D955BCUM11Paul BandittBCUM1 2023-12-11
D955BCUM21Paul BandittBCUM2 2023-12-11
D955BCUM241Paul BandittBCUM24 2023-12-11
D955BCUM31Paul BandittBCUM3 2023-12-11
D955BCUM41Paul BandittBCUM4 2023-12-11
D955BCUM7L1Paul BandittBCUM7L 2023-12-11

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