FDA.report

N/A

Primary DI
B5828018310
Brand
N/A
Company
GEORGE TIEMANN & CO.
Model
801831
Catalog number
801831
Device description
RETRACTOR, ALL TYPES
Published
2020-09-24
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

Contact Domains

Product Codes

CodeName
EIGRETRACTOR, ALL TYPES

Product Code Classifications

CodeDeviceSpecialtyClass
EIGRetractor, All TypesDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B5828018310PrimaryHIBCC0

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

Contacts

PhoneEmail
+1(631)273-0005stephen@georgetiemann.com

Regulatory Flags

DUNS number
107043630
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
false

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B58206513300N/A6513306513302020-09-24
B58206542700N/A6542706542702020-09-24
B58206543800N/A6543806543802020-09-24
B5820655105N/A6551056551052020-09-24
B582065700PP0N/A065700PP065700PP2020-09-24
B582065705STRFA0N/A065705STRFA065705STRFA2020-09-24
B5820705000N/A70500705002020-09-24
B582070609STFRA0N/A070609STFRA070609STFRA2020-09-24
B5820800800N/A80080800802020-09-24
B5820800810N/A80081800812020-09-24
B582080090450N/A800904580090452020-09-24
B582080090620N/A800906280090622020-09-24
B582080091620N/A800916280091622020-09-24
B5820800950N/A80095800952020-09-24
B58208009910N/A8009918009912020-09-24
B58208009930N/A8009938009932020-09-24
B58208009940N/A8009948009942020-09-24
B58208009950N/A8009958009952020-09-24

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