FDA.reportPublic FDA data

Paul Banditt

Primary DI
D955SPA241
Brand
Paul Banditt
Company
Terlain Enterprises, Inc.
Model
SPA24
Device description
PAUL BANDITT #24 SPATULA, SE
Published
2023-12-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GAFSpatula, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAFSpatula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D955SPA241PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
177465051
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D95516CASS1Paul Banditt16CASS2026-09-25
D9555CASS1Paul Banditt5CASS2026-09-25
D9558CASS1Paul Banditt8CASS2026-09-25
D955BBCG35450Paul BandittBBCG35452026-09-25
D955BBGA351Paul BandittBBGA352026-09-25
D955BBGA451Paul BandittBBGA452026-09-25
D955BBGA551Paul BandittBBGA552026-09-25
D955BBGA701Paul BandittBBGA702026-09-25
D955BDT11Paul BandittBDT12026-09-25
D955BDT21Paul BandittBDT22026-09-25
D955BDT31Paul BandittBDT32026-09-25
D955BDT61Paul BandittBDT62026-09-25
D955BDT71Paul BandittBDT72026-09-25
D955BDT81Paul BandittBDT82026-09-25
D955BDT91Paul BandittBDT92026-09-25
D955BLAHST1Paul BandittBLAHST2026-09-25
D955BMDG010Paul BandittBMDG-012026-09-25
D955BMDG021Paul BandittBMDG-022026-09-25
D955BMDG031Paul BandittBMDG-032026-09-25
D955BONDNG1Paul BandittBONDNG2026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850088713770PRINCETONPrinceton Medical Group, Inc.GAF2026-09-22
04054462902675evonosevonos GmbH & Co. KGGAF2026-08-21
04054462902682evonosevonos GmbH & Co. KGGAF2026-08-21
04054462902750evonosevonos GmbH & Co. KGGAF2026-08-21
04054462917495evonosevonos GmbH & Co. KGGAF2026-08-19
04054462901548evonosevonos GmbH & Co. KGGAF2026-08-18
04054462902699evonosevonos GmbH & Co. KGGAF2026-08-18
04054462902705evonosevonos GmbH & Co. KGGAF2026-08-18
04054462902712evonosevonos GmbH & Co. KGGAF2026-08-18
04054462902729evonosevonos GmbH & Co. KGGAF2026-08-18
04054462902736evonosevonos GmbH & Co. KGGAF2026-08-18
04054462902743evonosevonos GmbH & Co. KGGAF2026-08-18
B382SD571001EV0Surgical DirectSurgical Direct, Inc.GAF2026-08-03
B382SD571002EV0Surgical DirectSurgical Direct, Inc.GAF2026-08-03
B382SD571004EV0Surgical DirectSurgical Direct, Inc.GAF2026-08-03
08961104622548Spatula 6mm Single SidedMELPEX BEAUTY INSTRUMENTSGAF2026-05-21
08961104622555Spatula 8.0 mm Single SidedMELPEX BEAUTY INSTRUMENTSGAF2026-05-21
08961104622562Spatula 10 mm Single SidedMELPEX BEAUTY INSTRUMENTSGAF2026-05-21
00840343727352GEN2SURGIX MEDICAL LLCGAF2026-04-16
10889950147624Hu-FriedyHU-FRIEDY MFG. CO., LLCGAF2026-02-24
00840018668164Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCGAF2026-02-10
00840018662810Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCGAF2026-01-29
00840018662827Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCGAF2026-01-29
00810158218420PRINCETONPrinceton Medical Group, Inc.GAF2026-01-07
B382SD9150391000Surgical DirectSurgical Direct, Inc.GAF2025-12-29
B382SD9150391050Surgical DirectSurgical Direct, Inc.GAF2025-12-29
B382SD9150391060Surgical DirectSurgical Direct, Inc.GAF2025-12-29
B382SD9150471120Surgical DirectSurgical Direct, Inc.GAF2025-12-29
B382SD915095250Surgical DirectSurgical Direct, Inc.GAF2025-12-29
08800075627766OSUNG MNDOSUNG MND Co., Ltd.GAF2025-11-03