FDA.report

AESCULAP

Primary DI
04046964715532
Brand
AESCULAP
Company
AESCULAP, INC.
Model
MG248R
Catalog number
MG248R
Device description
, non-sterile, reusable
Published
2020-08-25
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
FGNRETRACTOR, NON-SELF-RETAINING

Product Code Classifications

CodeDeviceSpecialtyClass
FGNRetractor, Non-Self-RetainingGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046964715532PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046964715532040469647155324046964715532

GMDN Terms

TermDefinition
Self-retaining surgical retractor, reusableA hand-operated, self-retaining, one-piece 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 intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags

DUNS number
082594540
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04046964993312AESCULAPMG223RMG223R2026-01-16
04046964993329AESCULAPMG224RMG224R2026-01-16
04046955741212AESCULAPFK900NBFK900NB2025-08-17
04046955741229AESCULAPFK901NBFK901NB2025-08-17
04046955741236AESCULAPFK902NBFK902NB2025-08-17
04046955741243AESCULAPFK903NBFK903NB2025-08-17
04046955741250AESCULAPFK904NBFK904NB2025-08-17
04046955741267AESCULAPFK906NBFK906NB2025-08-17
04046955741274AESCULAPFK907NBFK907NB2025-08-17
04046955741281AESCULAPFK908NBFK908NB2025-08-17
04046955741298AESCULAPFK909NBFK909NB2025-08-17
04046955741304AESCULAPFK910NBFK910NB2025-08-17
04046955741311AESCULAPFK960NBFK960NB2025-08-17
04046955741328AESCULAPFK913NBFK913NB2025-08-17
04046955741335AESCULAPFK914NBFK914NB2025-08-17
04046955741342AESCULAPFK915NBFK915NB2025-08-17
04046955741359AESCULAPFK916NBFK916NB2025-08-17
04046955741366AESCULAPFK917NBFK917NB2025-08-17
04046955741373AESCULAPFK961NBFK961NB2025-08-17
04046955741380AESCULAPFK962NBFK962NB2025-08-17

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B382SD934117810Surgical DirectSurgical Direct, Inc.FGN2025-09-17
B382SD934117820Surgical DirectSurgical Direct, Inc.FGN2025-09-17
B382SD934117830Surgical DirectSurgical Direct, Inc.FGN2025-09-17
B382SD711510000Surgical DirectSurgical Direct, Inc.FGN2025-08-11
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B382SD914781140Surgical DirectSurgical Direct, Inc.FGN2025-07-23
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B382SD1417812310Surgical DirectSurgical Direct, Inc.FGN2025-02-20
00840319757611Hayden MedicalHayden Medical, Inc.FGN2025-01-10
00840319757628Hayden MedicalHayden Medical, Inc.FGN2025-01-10