FDA.reportPublic FDA data

AQUALOC®

Primary DI
00880304476141
Brand
AQUALOC®
Company
Biomet Orthopedics, LLC
Model
900383
Catalog number
900383
Published
2020-05-23
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
NBHAccessories, arthroscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBHAccessories, ArthroscopicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304476141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304476141008803044761418803044761410880304476141

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic obturatorA non-sterile, hand-held manual surgical instrument designed to fill the lumen of an arthroscopic sleeve (not included) to facilitate insertion of the sleeve into a joint (e.g., shoulder, knee) during arthroscopic examination or surgery. It is typically cannulated, made of metal, and available in a variety of sizes. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
129278169
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
00887868549236MULTI-DIRECTIONAL SCREW1312273081312273082022-11-14
00887868549243MULTI-DIRECTIONAL SCREW1312273091312273092022-11-14
00887868549250MULTI-DIRECTIONAL SCREW1312273101312273102022-11-14
00887868549267MULTI-DIRECTIONAL SCREW1312273111312273112022-11-14
00887868549274MULTI-DIRECTIONAL SCREW1312273121312273122022-11-14
00887868549281MULTI-DIRECTIONAL SCREW1312273131312273132022-11-14
00887868549298MULTI-DIRECTIONAL SCREW1312273141312273142022-11-14
00887868549304MULTI-DIRECTIONAL SCREW1312273151312273152022-11-14
00887868549311MULTI-DIRECTIONAL SCREW1312273161312273162022-11-14
00887868549328MULTI-DIRECTIONAL SCREW1312273181312273182022-11-14
00887868549335MULTI-DIRECTIONAL SCREW1312273201312273202022-11-14
00887868549342MULTI-DIRECTIONAL SCREW1312273221312273222022-11-14
00887868549359MULTI-DIRECTIONAL SCREW1312273241312273242022-11-14
00887868549366MULTI-DIRECTIONAL SCREW1312273261312273262022-11-14
00887868549373MULTI-DIRECTIONAL SCREW1312273281312273282022-11-14
00887868549380MULTI-DIRECTIONAL SCREW1312273301312273302022-11-14
00887868544699SMOOTH PEG1312270081312270082022-09-07
00887868544705SMOOTH PEG1312270091312270092022-09-07
00887868544712SMOOTH PEG1312270101312270102022-09-07
00887868544729SMOOTH PEG1312270111312270112022-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD319590Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD480084LH0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD48008SLH0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481014SLH0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481022LH0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481752CBDYN0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481752PT0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481755STR0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481756STR0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481760DYN0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD483003STR0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD487193000Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD487223000Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD5235320Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD142090Surgical DirectSurgical Direct, Inc.NBH2026-07-31
B382SD1814DK70Surgical DirectSurgical Direct, Inc.NBH2026-07-31
B382SD18252590Surgical DirectSurgical Direct, Inc.NBH2026-07-31
B382SD30609CH0Surgical DirectSurgical Direct, Inc.NBH2026-07-31
B382SD316390Surgical DirectSurgical Direct, Inc.NBH2026-07-31
00198506093258ELMED INCORPORATEDELMED INCORPORATEDNBH2026-07-28
00810143908534SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909449SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909456SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909463SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909470SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909487SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909494SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909500SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909531SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909555SURGIPROSSurgipros, LLCNBH2026-07-28