FDA.report

AESCULAP

Primary DI
04046964587191
Brand
AESCULAP
Company
AESCULAP, INC.
Model
MA434R
Catalog number
MA434R
Device description
SEWALL Wound Retractor (With Blade), 6 3/4", (170 mm), 7 x 52 mm, non-sterile, reusable
Published
2020-05-08
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
HNIRetractor, ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNIRetractor, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046964587191PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046964587191040469645871914046964587191

GMDN Terms

TermDefinition
Periocular/lacrimal retractor, hand-held, reusableA hand-held, non-self-retaining, ophthalmic surgical instrument intended to be used to separate periocular tissues and/or draw aside the margins of a periocular surgical wound during an ophthalmic intervention (e.g., eyelid retraction, lacrimal sac access). The instrument is typically designed with a shaped/hooked blade or flat plate (e.g., eyelid plate) with a handle/holding portion, and is usually made of metal. 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

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