PMT CORPORATION HALO

GUDID 00650551146933

OPEN BACK RING – LARGE, (5)3" SKULL PINS, (3)POSITIONING PINS, 21 PIN SITES

PMT CORPORATION

Cervical spine immobilization system, single-use
Primary Device ID00650551146933
NIH Device Record Key01cff2a8-1cdf-4af2-9745-db50c8d94d60
Commercial Distribution StatusIn Commercial Distribution
Brand NamePMT CORPORATION HALO
Version Model Number1211-1LE
Company DUNS039576871
Company NamePMT CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100650551146933 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAXTong, Skull For Traction

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-20
Device Publish Date2021-07-12

On-Brand Devices [PMT CORPORATION HALO]

00650551143734TRACTION BAIL, FOR DIRECT ATTACHMENT TO A HALO RING
00650551142874LOCKING HALO ROD CLAMPS, SET OF 8
006505511425911211-1 OPEN BACK HALO RING, X-SMALL, (10) 2 1/2" PINS AND (3) POSITIONING PINS
006505511425081211-1 OPEN BACK HALO RING, XX-LARGE, INCLUDES (5) 3" SKULL PINS AND (3) POSITIONING PINS
00650551141686TRACTION BAIL HARDWARE - (2) 3/4" SHCS, (2) WASHERS, (1) ALLEN WRENCH
00650551144014TRACTION BAIL, SHORT
00650551146964HEADBLOCK PARTS REPLACEMENT KIT: (4) 1 3/4" SHCS, (8) WASHERS, (4) LOCK WASHERS, (8) SET SCREWS,
00650551146933OPEN BACK RING – LARGE, (5)3" SKULL PINS, (3)POSITIONING PINS, 21 PIN SITES
00650551146926OPEN BACK RING – MEDIUM, (5)3" SKULL PINS, (3)POSITIONING PINS, 21 PIN SITES
00650551146919OPEN BACK RING – SMALL, (5)3" SKULL PINS, (3)POSITIONING PINS, 21 PIN SITES
00650551146407BLACK KNOB FOR SURGICAL BED ADAPTER
00650551148982CUSTOM VEST
006505511486091223-5 CUSTOM HALO VEST WITH AIRBAG, LAMBSWOOL LINER, REQUIRES SIZING MEASUREMENT TO ORDER

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