FDA.reportPublic FDA data

Minnesota Cheek Retractor

Primary DI
00810060723289
Brand
Minnesota Cheek Retractor
Company
Berman Instruments LLC
Model
RM001
Published
2022-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810060723289PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810060723289008100607232898100607232890810060723289

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

Regulatory Flags#

DUNS number
118744340
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
00810060722015Adson Tissue ForcepsAF0012022-09-22
00810060722039Aspirating Syringe 1.8 mlAS0182022-09-22
00810060722077Lucas Curette #85BC085 2022-09-22
00810060722084Lucas Curette #87BC0872022-09-22
00810060722091Lucas Curette #88BC0882022-09-22
008100607221072R/2L Columbia Curette CC022 2022-09-22
008100607221144R/4L Columbia Curette CC044 2022-09-22
0081006072212113/14 Columbia CuretteCC1342022-09-22
008100607221381/2 Gracey CG012 2022-09-22
0081006072214511/12 Gracey CG112 2022-09-22
0081006072215213/14 Gracey CG134 2022-09-22
0081006072220613K/TG Kirkland Periodontal ChiselCKP13 2022-09-22
008100607222204 Ochsenbein Surgical Chisel, 3.4 mmCOS04 2022-09-22
00810060722237College Pliers, Serrated Tips CP001 2022-09-22
00810060722244113 Non-serrated Cord Packer CP113 2022-09-22
00810060722251College Pliers, Self-locking, Serrated Tips CPL02 2022-09-22
00810060722558Rubber dam punch DF002 2022-09-22
00810060722657Molt #2 Surgical CuretteEP002 2022-09-22
00810060722930Molt Mouth Prop - Adult MA002 2022-09-22
00810060722947Metal Bowl - Prep CupMBPC352 2022-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091872ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-10
00810158211193PRINCETONPrinceton Medical Group, Inc.GAD2026-07-10
00810158219861PRINCETONPrinceton Medical Group, Inc.GAD2026-07-10
00888937033687ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033694ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033700ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033717ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033724ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033731ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033748ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033755ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033762ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033779ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033786ONETRAC™ LXSCoopersurgical, Inc.GAD2026-07-10
00888937033793ONETRAC™ LXSCoopersurgical, Inc.GAD2026-07-10
00888937033809ONETRAC™ LXSCoopersurgical, Inc.GAD2026-07-10
00888937033816ONETRAC™ LXSCoopersurgical, Inc.GAD2026-07-10
07640177823564Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823571Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823588Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823595Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823601Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823748Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823755Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823762Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823779Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823786Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823793Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823809Neo Medical RetractorsNeo Medical SAGAD2026-07-10
B382SD9044561000Surgical DirectSurgical Direct, Inc.GAD2026-07-10