FDA.report

AESCULAP

Primary DI
04046964685774
Brand
AESCULAP
Company
AESCULAP, INC.
Model
MA838R
Catalog number
MA838R
Device description
BORES OPTICAL ZONE MARKER 3.5MM 100MM
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
HMRMarker, ocular

Product Code Classifications

CodeDeviceSpecialtyClass
HMRMarker, OcularOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046964685774PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046964685774040469646857744046964685774

GMDN Terms

TermDefinition
Scleral marker, reusableA manual instrument intended to be used to indent or imprint the surface of the sclera during an ophthalmic surgical or perioperative procedure. It is typically a hand-held instrument or a thimble-like device (placed on the end of a finger) and is made of metal (e.g., high-grade stainless steel). Various types are available, including the Gass scleral marker that creates a minuscule indentation, the Awh scleral marker that creates parallel scored lines, and the Awh horseshoe design. The device is typically used for retinal detachment surgery. 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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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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