FDA.reportPublic FDA data

Karl Schumacher

Primary DI
00842517114432
Brand
Karl Schumacher
Company
Karl Schumacher Dental, LLC
Model
RET0308A
Device description
Austin Retractor #308A
Published
2024-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIGRETRACTOR, ALL TYPES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIGRetractor, All TypesDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842517114432PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842517114432008425171144328425171144320842517114432

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. 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
Premarket exempt
true
Lot or batch
true
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
00842517108547Karl SchumacherELX0012L2024-03-18
00842517108554Karl SchumacherELX0012R2024-03-18
00842517108561Karl SchumacherELX0013L2024-03-18
00842517108578Karl SchumacherELX0013R2024-03-18
00842517108622Karl SchumacherELX03202024-03-18
00842517108639Karl SchumacherELX03212024-03-18
00842517108660Karl SchumacherELX03502024-03-18
00842517108677Karl SchumacherELX03512024-03-18
00842517104129Karl SchumacherASP0000Y2025-04-23
00842517112568Karl SchumacherNEE06862025-04-23
00842517112582Karl SchumacherNEE06892025-04-23
00842517112599Karl SchumacherNEE06902025-04-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08961104622197Cheek Retractor SmallMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622203Cheek Retractor SmallMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622210Cheek RetractorMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622227Cheek RetractorMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622234Lip RetractorMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622241Cheek Retractor SmallMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622258Cheek Retractor SmallMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622265Cheek RetractorMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622272Cheek RetractorMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622289Lip RetractorMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
10304040196998Henry ScheinHENRY SCHEIN, INC.EIG2026-05-14
10304040197001Henry ScheinHENRY SCHEIN, INC.EIG2026-05-14
10304040197018Henry ScheinHENRY SCHEIN, INC.EIG2026-05-14
00348783010220Premier RetractorsPREMIER DENTAL PRODUCTS COMPANYEIG2026-05-06
G149NP260020NPSACME ENTERPRISE.EIG2026-05-01
G149NPORR0NPSACME ENTERPRISE.EIG2026-05-01
00371347023459Advance Dental ProductsThe Atlanta Dental Supply CompanyEIG2026-04-14
B382SD9144082080Surgical DirectSurgical Direct, Inc.EIG2026-02-12
B382SD9210921010Surgical DirectSurgical Direct, Inc.EIG2026-02-12
00841336128828Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIG2025-11-04
00190707191153Ortho Technology®Ortho Organizers, Inc.EIG2025-10-23
00190707191160Ortho Technology®Ortho Organizers, Inc.EIG2025-10-23
B382SD5615280Surgical DirectSurgical Direct, Inc.EIG2025-10-06
B382SD5640120Surgical DirectSurgical Direct, Inc.EIG2025-10-06
B382SD5640140Surgical DirectSurgical Direct, Inc.EIG2025-10-06
B382SD5640160Surgical DirectSurgical Direct, Inc.EIG2025-10-06
B382SD5640180Surgical DirectSurgical Direct, Inc.EIG2025-10-06
B382SD5640200Surgical DirectSurgical Direct, Inc.EIG2025-10-06
B382SD5640220Surgical DirectSurgical Direct, Inc.EIG2025-10-06
B382SD5640300Surgical DirectSurgical Direct, Inc.EIG2025-10-06