FDA.reportPublic FDA data

Spatula 8.0 mm Single Sided

Primary DI
08961104622555
Brand
Spatula 8.0 mm Single Sided
Company
MELPEX BEAUTY INSTRUMENTS
Model
Solid Handle
Catalog number
23-026
Device description
Spatula 8.0 mm Single Sided Solid Handle
Published
2026-05-21
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
08961104622555PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08961104622555089611046225558961104622555

GMDN Terms#

Term, Definition table
TermDefinition
Dental spatula, reusableA hand-held manual dental device used to manipulate filling materials in the plastic state. It is typically made of stainless steel with a small, flat, blunt blade (no sharp edges) at one end, or it may be double-ended. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
645674404
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08961104621824Mathieu Standard TipDouble Spring15-006D2026-05-21
08961104621831Mathieu Standard TipSingle Spring15-006S2026-05-21
08961104621848Mathieu Standard Tip TCDouble Spring15-006DTC2026-05-21
08961104621855Mathieu Standard Tip TCSingle Spring15-006STC2026-05-21
08961104621862Mathieu Narrow TipDouble Spring15-002D2026-05-21
08961104621879Mathieu Narrow TipSingle Spring15-002S2026-05-21
08961104621886Mathieu Narrow Tip TCDouble Spring15-002DTC2026-05-21
08961104621893Mathieu Narrow Tip TCSingle Spring15-002STC2026-05-21
08961104621909Mathieu Narrow Tip HalfDouble Spring15-016D2026-05-21
08961104621916Mathieu Narrow Tip HalfSingle Spring15-016S2026-05-21
08961104621923Mathieu Hook TipDouble Spring15-014D2026-05-21
08961104621930Mathieu Hook TipSingle Spring15-014S2026-05-21
08961104621947Mathieu Hole TipDouble Spring15-008D2026-05-21
08961104621954Mathieu Hole TipSingle Spring15-008S2026-05-21
08961104621961Mathieu Hook Tip GroovedDouble Spring15-014GD2026-05-21
08961104621978Mathieu Hook Tip GroovedSingle Spring15-014GS2026-05-21
08961104621985Mathieu Smaha Ultra Fine TipSingle Spring20-020S 2026-05-21
08961104621992Mathieu Smaha Ultra Fine TipDouble Spring20-020D2026-05-21
08961104622142Strip PlacerStrip Placer16-261A2026-05-21
08961104622159polar bear Martensitic positionerMartensitic positioner16-2612026-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08961104622548Spatula 6mm 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
00810158217652PRINCETONPrinceton Medical Group, Inc.GAF2025-10-17
00810158217669PRINCETONPrinceton Medical Group, Inc.GAF2025-10-17
B382SD571002EM0Surgical DirectSurgical Direct, Inc.GAF2025-10-06
B382SD572425E0Surgical DirectSurgical Direct, Inc.GAF2025-10-06
00810158217263PRINCETONPrinceton Medical Group, Inc.GAF2025-09-25
04250676741431SpatulaSpiggle & Theis Medizintechnik GmbHGAF2025-09-24
04250676741448SpatulaSpiggle & Theis Medizintechnik GmbHGAF2025-09-24
04250676741455SpatulaSpiggle & Theis Medizintechnik GmbHGAF2025-09-24
B382SD915095450Surgical DirectSurgical Direct, Inc.GAF2025-08-11
00840343725792GEN2SURGIX MEDICAL LLCGAF2025-06-16
00840343725808GEN2SURGIX MEDICAL LLCGAF2025-06-16
00840343725815GEN2SURGIX MEDICAL LLCGAF2025-06-16
10649111448614Sklar InstrumentsSKLAR CORPORATIONGAF2025-05-29
50649111448612Sklar InstrumentsSKLAR CORPORATIONGAF2025-05-29
B382SD915039100Surgical DirectSurgical Direct, Inc.GAF2025-05-19
B382SD915039120Surgical DirectSurgical Direct, Inc.GAF2025-05-19