FDA.reportPublic FDA data

AESCULAP

Primary DI
04046955074570
Brand
AESCULAP
Company
AESCULAP, INC.
Model
ER212R
Catalog number
ER212R
Device description
THOMAS Uterine Curette, (280 mm), malleable, Fig. 2
Published
2020-08-02
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HCYCURETTE, UTERINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCYCurette, UterineObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046955074570PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046955074570040469550745704046955074570

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose curetteA hand-held manual surgical instrument designed for scraping and/or excising tissue from a wide variety of anatomical sites, and includes at least one non-dermal application (i.e., non-dedicated). It is typically made of high-grade stainless steel, available in a variety of shapes and sizes, and has an appropriately-shaped distal end (e.g., cup-, ring-, spoon-like). This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
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 DI, Brand, Model table
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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Primary DI, Brand, Company table
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