FDA.reportPublic FDA data

AESCULAP

Primary DI
04046963848071
Brand
AESCULAP
Company
Aesculap AG
Model
PL818R
Catalog number
PL818R
Device description
"Clip Removing Forceps, single-fire, 12 1/4"", (310 mm), diam. 12 mm, Size L, orange, reusable, to be used with: PL468SU, PL471SU"
Published
2020-04-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDOApplier, surgical, clip

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDOApplier, Surgical, ClipGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046963848071PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046963848071040469638480714046963848071

GMDN Terms#

Term, Definition table
TermDefinition
Surgical staple remover, reusableA surgical instrument made of metal or plastic that is used to remove surgical staples after the healing process has progressed sufficiently to permit the borders of the wound or incision to remain together without assistance. It is typically made of high-grade stainless steel with blades at the distal end designed for grasping, opening, and removing surgical staples. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

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
14026704928702WECKTELEFLEX INCORPORATEDGDO2026-08-25
14026704928436WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928443WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928450WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928467WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928474WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928481WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928498WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928504WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928511WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928528WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928535WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928542WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928559WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928566WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928573WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928580WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928597WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928603WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928610WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928627WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928634WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928641WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928658WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928665WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928672WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928689WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928696WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928719WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928726WECKTELEFLEX INCORPORATEDGDO2026-08-21