FDA.report

SoftGrip Forceps SR

Primary DI
09008737583934
Brand
SoftGrip Forceps SR
Company
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
Model
58393
Catalog number
58393
Device description
SoftGrip Forceps SR (Ms050208)
Published
2021-04-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KAEForceps, Ent

Product Code Classifications

CodeDeviceSpecialtyClass
KAEForceps, EntEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
09008737583934PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
09008737583934090087375839349008737583934

GMDN Terms

TermDefinition
Surgical implant handling forcepsA hand-held manual surgical instrument with blades designed to grasp and manipulate a surgical implant (excluding sutures) during implantation; it is not intended for use on tissues, is not a dental or ophthalmic device, and is not a dedicated tissue clip applier. It is made of metal materials and may have one of various designs (e.g., tweezers-, scissors-, alligator-like) whereby the blades are designed to be opened/closed to handle a variety of implantable devices (e.g., orthopaedic joint prosthesis, breast implant, surgical mesh). This is a reusable device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
1-888-633-3524implants.us@medel.com

Regulatory Flags

DUNS number
300764032
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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