FDA.report

Black Coated Minnesota Cheek Retractor

Primary DI
00810060723562
Brand
Black Coated Minnesota Cheek Retractor
Company
Berman Instruments LLC
Model
RMBC1
Published
2022-09-21
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

Related Records

Product Codes

CodeName
EIGRetractor, All Types

Product Code Classifications

CodeDeviceSpecialtyClass
EIGRetractor, All TypesDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810060723562PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810060723562008100607235628100607235620810060723562

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
118744340
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

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00810060722015Adson Tissue ForcepsAF0012022-09-22
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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

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