FDA.reportPublic FDA data

Spatula & Curette Pack

Primary DI
15060238201329
Brand
Spatula & Curette Pack
Company
SUMMIT MEDICAL LIMITED
Model
SC01
Device description
Spatula & Curette Pack
Published
2022-08-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTFCurette

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTFCuretteGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
25060238201326PackageGS110Not in Commercial Distribution
15060238201329PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2506023820132625060238201326
1506023820132915060238201329

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement preparation/delivery kitA collection of sterile surgical instruments, tools, and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e.g., hip replacement, arthroplasty, or vertebroplasty). It typically includes items such as forceps, a mallet, cement delivery injectors, delivery tubes, and mixing devices; it may or may not include bone cement. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+441451821311info@summit-medical.co.uk

Regulatory Flags#

DUNS number
221751311
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15060238201923Vacuum Cement Mixing Bowl1400-21001400-21002025-11-18
25060238201920Vacuum Cement Mixing Bowl1400-21001400-21002025-11-18
15060238201138CellTrans ABT45102018-12-21
15060238201596Femoral Cement PressuriserP721P7212025-01-10
15060238201633HiVac™ 7 Triple Mix C703C7032025-01-10
15060238201657HiVac™ 7 with Femoral Cement Pressuriser CP701CP7012025-01-10
15060238201671HiVac™ SyringeS727S7272025-01-10
15060238201688HiVac™ SyringeS717WS717W2025-01-10
150602382017189mm Nozzle With Nozzle ExtruderN700N7002025-01-10
15060238201725Quick-Vac® Vacuum Mixing Bowl00504900100005049001002025-01-10
15060238201732Quick-Vac® Vacuum Mixing Bowl00504900115005049001152025-01-10
15060238201749HiVac BowlB713B7132025-01-10
15060238201756Rally™ Vacuum Mixing Bowl7127-18017127-18012025-01-10
15060238201770Cement Mixing and Delivery System00-4501-090-0000-4501-090-002025-01-10
15060238201787 MiniMix™SMMM1SMMM12025-01-10
15060238201794MiniMix™ LVSMLVSMLV2025-01-10
15060238201800MiniMix™ Delivery SyringeSMDS1CSMDS1C2025-01-10
15060238201886Mixing bowl, SpatulaB710B7102025-01-10
25060238201593Femoral Cement PressuriserP721P7212025-01-10
25060238201630HiVac™ 7 Triple Mix C703C7032025-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810168190464NAPACIFIC INSTRUMENTS, INC.HTF2026-07-06
B803PS0099100A0ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS00991080ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS0099108A0ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS00991090ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS0099109A0ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS00991100ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS0099110A0ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS0395900ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS03959000ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS039590000ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS0395910ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS0395920ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS0395930ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS0395950ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS0395960ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS0595940ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS00991010ORTHOMEDORTHO-MED, INC.HTF2026-06-25
B803PS0099101A0ORTHOMEDORTHO-MED, INC.HTF2026-06-25
B803PS00991020ORTHOMEDORTHO-MED, INC.HTF2026-06-25
B803PS0099102A0ORTHOMEDORTHO-MED, INC.HTF2026-06-25
B803PS00991030ORTHOMEDORTHO-MED, INC.HTF2026-06-25
B803PS0099103A0ORTHOMEDORTHO-MED, INC.HTF2026-06-25
B803PS00991040ORTHOMEDORTHO-MED, INC.HTF2026-06-25
B803PS0099104A0ORTHOMEDORTHO-MED, INC.HTF2026-06-25
B803PS00991050ORTHOMEDORTHO-MED, INC.HTF2026-06-25
B803PS0099105A0ORTHOMEDORTHO-MED, INC.HTF2026-06-25
B803PS00991060ORTHOMEDORTHO-MED, INC.HTF2026-06-25
B803PS0099106A0ORTHOMEDORTHO-MED, INC.HTF2026-06-25
B803PS00991070ORTHOMEDORTHO-MED, INC.HTF2026-06-25