FDA.reportPublic FDA data

AVALIGN

Primary DI
00850011214183
Brand
AVALIGN
Company
PROGRESSIVE MEDICAL INSTRUMENTATION INC
Model
PMI-LK75-2974/09
Catalog number
PMI-LK75-2974/09
Device description
"IVD RONG STR 5X10MM 11.75"""
Published
2019-09-06
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
HAERongeur, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAERongeur, ManualNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850011214183PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850011214183008500112141838500112141830850011214183

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic joint/limb rongeurA hand-held manual surgical instrument designed to remove bone during an orthopaedic intervention of the limbs/joints; it is not primarily intended for nasal, spinal, or cranial use and is not a dedicated rib rongeur. It is a heavy-duty metallic instrument that has a forceps- or pliers-like design and terminates at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws to bite (cut) through the bone. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
5022671100ORDERS@PMIREPAIRS.COM

Regulatory Flags#

DUNS number
131054074
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850011214442ELMEDPMI23-40045STRPMI23-40045STR2019-12-06
00850011214404AVALIGNPMI-HD-SPMI-HD-S2019-11-20
00850011214411AVALIGNPMI-B-2VPMI-B-2V2019-11-20
00850011214428AVALIGNPMI-B-3VPMI-B-3V2019-11-20
00850011214435AVALIGNPMI-ABB-11VPMI-ABB-11V2019-11-20
00850011214299AVALIGNPMI-ABB-33VPMI-ABB-33V2019-09-20
00850011214282AVALIGNPMI-ABB-22VPMI-ABB-22V2019-09-18
00850011214077AVALIGNPMI-RD-DPMI-RD-D2019-09-06
00850011214084AVALIGNPMI-HD-DPMI-HD-D2019-09-06
00850011214091AVALIGNPMI-DC-1-BPMI-DC-1-B2019-09-06
00850011214107AVALIGNPMI-B3-VBPMI-B3-VB2019-09-06
00850011214497ELMEDPMI37-500707PMI37-5007072020-02-18
00850011214473ELMEDPMI59-8010BMPMI59-8010BM2020-01-03
00850011214459ELMEDPMI52-25560B1PMI52-25560B12019-12-23
00850011214466ELMEDPMI52-25566B1PMI52-25566B12019-12-23
00850011214381ELMEDPMI52-25571A1PMI52-25571A12019-11-15
00850011214398ELMEDPMI52-205100PMI52-2051002019-11-15
00850011214374ELMEDPMI52-00548PMI52-005482019-11-01
00850011214329ELMEDPMI422010PMI4220102019-10-01
00850011214336ELMEDPMI425301PMI4253012019-10-01

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Primary DI, Brand, Company table
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G277G2N732330GEN2SURGIX MEDICAL LLCHAE2022-09-28
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