FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653037056
Brand
AESCULAP
Company
Aesculap AG
Model
DL373R
Catalog number
DL373R
Device description
"Root Elevator, curved, 6"", (150 mm), handle with thumb depression, Fig. 3C, width: 3,500 mm, non-sterile, reusable"
Published
2020-05-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMJELEVATOR, SURGICAL, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMJElevator, Surgical, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653037056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653037056040386530370564038653037056

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery dissectorA hand-held surgical instrument, usually spoon-shaped or rounded at the working end, used to separate a soft tissue or body structure from another. It is used in general or plastic surgery and is usually designed with a handle which continues into a shaft that terminates at the distal end with a tip. The tip may be pointed or flat, sharp or blunt, and angled or straight from the shaft. It is made of high-grade stainless steel, comes in various shapes and sizes. 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
315018218
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04038653434022AESCULAPFT944TFT944T2015-09-24
04046963417468AESCULAPFT942TFT942T2015-09-24
04038653042586AESCULAPET251RET251R2016-09-23
04046964227547AESCULAPGF058BGF058B2016-09-23
04038653148998AESCULAPDO706RDO706R2020-04-21
04038653105878AESCULAPLS059RLS059R2020-04-21
04038653106080AESCULAPLS099RLS099R2020-04-21
04038653034666AESCULAPDE419RDE419R2020-06-17
04038653034697AESCULAPDE422RDE422R2020-06-17
04038653105977AESCULAPLS084RLS084R2022-07-29
04038653199020AESCULAPXG105RXG105R2021-10-15
04038653199006AESCULAPXG103RXG103R2020-08-24
04038653199013AESCULAPXG104RXG104R2020-08-24
04038653460533AESCULAPXG106RXG106R2020-08-24
04046963000431AESCULAPXG107RXG107R2020-08-24
04046963000448AESCULAPXG108RXG108R2020-08-24
04046963611538AESCULAPXG126RXG126R2020-08-24
04038653109999AESCULAPND118RND118R2020-05-08
04038653110018AESCULAPND121RND121R2020-05-08
04038653110056AESCULAPND125RND125R2020-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D955BDT11Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955BDT21Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955BDT31Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955BDT61Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955BDT71Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955BDT81Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955BDT91Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955ELE461Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955ELE571Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955ELE581Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955ELE77RW1Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
G879LXB50DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-25
G879103420TIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-14
G8791034210DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-14
G8791034220DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-14
G879106049TIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-14
G8791061050DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-14
G8791061170DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-14
G879101067S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-13
G879101067L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-13
G879101067M0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-13
G879101068L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-13
G879101068M0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-13
G879101068S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-13
00190776408688MillenniumAvalign Technologies, Inc.EMJ2026-08-03
00190776400224MillenniumAvalign Technologies, Inc.EMJ2026-07-21
00190776403706MillenniumAvalign Technologies, Inc.EMJ2026-07-21
00190776395506MillenniumAvalign Technologies, Inc.EMJ2026-07-14
00190776395513MillenniumAvalign Technologies, Inc.EMJ2026-07-14
00190776395544MillenniumAvalign Technologies, Inc.EMJ2026-07-14