FDA.reportPublic FDA data

AESCULAP

Primary DI
04046964608032
Brand
AESCULAP
Company
AESCULAP, INC.
Model
MG160R
Catalog number
MG160R
Device description
CHELSEA EATON ANAL SPECULUM 65MM X 22MM
Published
2020-10-12
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
FFQSPECULUM, RECTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFQSpeculum, RectalGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046964608032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964608032040469646080324046964608032

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining 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 dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506087691ELMED INCORPORATEDELMED INCORPORATEDFFQ2026-01-16
00198506085376ELMED INCORPORATEDELMED INCORPORATEDFFQ2025-09-09
00198506085017ELMED INCORPORATEDELMED INCORPORATEDFFQ2025-09-05
00190776409180MillenniumAvalign Technologies, Inc.FFQ2025-08-22
00190776409265MillenniumAvalign Technologies, Inc.FFQ2025-08-22
00190776409272MillenniumAvalign Technologies, Inc.FFQ2025-08-22
00190776408299MillenniumAvalign Technologies, Inc.FFQ2025-08-07
00198506084201ELMED INCORPORATEDELMED INCORPORATEDFFQ2025-07-17
00190776402983MillenniumAvalign Technologies, Inc.FFQ2025-06-30
00190776399627MillenniumAvalign Technologies, Inc.FFQ2025-06-02
00190776399634MillenniumAvalign Technologies, Inc.FFQ2025-06-02
00190776399764MillenniumAvalign Technologies, Inc.FFQ2025-06-02
04049047074663GimmiGimmi GmbHFFQ2025-05-20
04049047074670GimmiGimmi GmbHFFQ2025-05-20
04049047316848GimmiGimmi GmbHFFQ2025-05-20
00190776393717MillenniumAvalign Technologies, Inc.FFQ2025-05-06
00190776393724MillenniumAvalign Technologies, Inc.FFQ2025-05-06
00190776393731MillenniumAvalign Technologies, Inc.FFQ2025-05-06
00190776393748MillenniumAvalign Technologies, Inc.FFQ2025-05-06
00190776393755MillenniumAvalign Technologies, Inc.FFQ2025-05-06
00198506082610ELMED INCORPORATEDELMED INCORPORATEDFFQ2025-05-06
00190776393182MillenniumAvalign Technologies, Inc.FFQ2025-05-05
00198506082375ELMED INCORPORATEDELMED INCORPORATEDFFQ2025-04-21
00198506081248ELMED INCORPORATEDELMED INCORPORATEDFFQ2025-03-14
00198506075537ELMED INCORPORATEDELMED INCORPORATEDFFQ2025-02-21
00198506074066ELMED INCORPORATEDELMED INCORPORATEDFFQ2025-01-03
00198506073816ELMED INCORPORATEDELMED INCORPORATEDFFQ2024-12-19
00190776389918MillenniumAvalign Technologies, Inc.FFQ2024-11-18
00190776389130MillenniumAvalign Technologies, Inc.FFQ2024-11-14
00198506073243ELMED INCORPORATEDELMED INCORPORATEDFFQ2024-11-11