FDA.reportPublic FDA data

Karl Schumacher

Primary DI
00842517102811
Brand
Karl Schumacher
Company
Karl Schumacher Dental, LLC
Model
41.822.04
Device description
Stiller Univ Sinus Lift Cur, 3.0mm. Yel
Published
2024-02-27
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMKCURETTE, SURGICAL, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMKCurette, Surgical, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842517102811PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842517102811008425171028118425171028110842517102811

GMDN Terms#

Term, Definition table
TermDefinition
Periosteal elevator, reusableA hand-held manual surgical instrument designed to lift/separate (elevate) or tunnel under the periosteum during surgery, typically orthopaedic, including use on the ribs. It may in addition be used in dentistry to access retained roots, or to remove them with surrounding bone. It is typically a one-piece instrument available in a variety of sizes and blade designs, including straight and curved blades, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)523-2427custsvs@karlschumacher.com

Regulatory Flags#

DUNS number
101070070
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842517104747Karl SchumacherASP0016T2025-07-08
00842517112360Karl SchumacherNEE00022025-07-08
00842517112384Karl SchumacherNEE00062025-07-08
00842517112421Karl SchumacherNEE00082025-07-08
00842517112438Karl SchumacherNEE0008T2025-07-08
00842517112476Karl SchumacherNEE00112025-07-08
00842517112483Karl SchumacherNEE00122025-07-08
00842517116764Karl SchumacherSCI0667S2025-06-19
00842517104129Karl SchumacherASP0000Y2025-04-23
00842517112568Karl SchumacherNEE06862025-04-23
00842517112582Karl SchumacherNEE06892025-04-23
00842517112599Karl SchumacherNEE06902025-04-23
00842517112629Karl SchumacherNEE06912025-04-23
00842517112780Karl SchumacherNEE07902025-04-23
00842517112803Karl SchumacherNEE07912025-04-23
00842517111417Karl SchumacherHEM06102025-02-05
00842517111424Karl SchumacherHEM06112025-02-05
00842517112209Karl SchumacherMOS06122025-02-05
00842517112216Karl SchumacherMOS06132025-02-05
00842517103603Karl SchumacherAMCBGMS2024-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783007831Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMK2026-03-17
B382SD9162110970Surgical DirectSurgical Direct, Inc.EMK2026-03-02
B382SD916211098Surgical DirectSurgical Direct, Inc.EMK2026-03-02
B382SD9162111000Surgical DirectSurgical Direct, Inc.EMK2026-03-02
G1493800400TBS DentalACME ENTERPRISE.EMK2026-03-02
G1493800501TBS DentalACME ENTERPRISE.EMK2026-03-02
G1493806204TBS DentalACME ENTERPRISE.EMK2026-03-02
G149TBSBP03TBS DentalACME ENTERPRISE.EMK2026-03-02
B382SD915585140Surgical DirectSurgical Direct, Inc.EMK2026-02-25
B382SD48713950600Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD48800200Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD48800240Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD48810120Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD9155000200Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD9155000500Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD915570020Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD915570050Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD915579000Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD915580070Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD9155911020Surgical DirectSurgical Direct, Inc.EMK2026-02-04
00841336106000Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2025-12-22
00841336106062Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2025-12-22
00841336106079Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2025-12-22
00841336106239Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2025-12-22
00841336106499Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2025-12-22
00841336106697Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2025-12-22
00841336106918Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2025-12-22
00841336108639Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2025-12-22
00841336108653Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2025-12-22
00841336109421Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2025-12-22